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Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.
Objectives of the study:
The study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors The study is scheduled to begin in May 2018, the supposed completion of the study is December 2020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with bowel diseases | Experimental | Treatment by transplantation of fecal microbiota |
|
| autologous transplantation of fecal microbiota - healthy | Experimental | Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules) |
|
| Both autologous and heterologous transplantation - healthy | Experimental | Healthy volunteers will receive both autologous and heterologous transplantation (capsules) |
|
| placebo capsules - healthy | Placebo Comparator | Healthy volunteers will receive placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Other | Fecal Microbiota Transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcerative Colitis remission | Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3 | 1 month after transplantation. Change from Baseline - 1 day before transplantation |
| Crohn Disease remission | Crohn Disease remission defined as a Harvey-bradshaw index <3. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Ulcerative Colitis symptoms. | Defined as improvement in SCCAI. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. |
| Change in gut microbiome | Diversity and variability of gut microbiome. |
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Inclusion Criteria:
the age of patients - from 18 to 75 years, both sexes;
Patients with:
Absence of contraindications to gastroscopy
informed consent of the patient for the transplant procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Ilina, MD | FRCC PCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FRCC PCM | Moscow | Russia |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D043183 | Irritable Bowel Syndrome |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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In total, 85 participants must be registered. 35 are healthy volunteers. Of these volunteers, 15 will receive autologous transplantation of fecal microbiota, 10 will receive both autologous and heterologous transplantation and 10 volunteers form a placebo-controlled group.
50 participants will form a treatment group.
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| 1 month after transplantation. Change from Baseline - 1 day before transplantation. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003109 | Colonic Diseases, Functional |